Luminal anastomotic device and method

ABSTRACT

An end to end anastomotic stapling device connects two lumen sections avoiding constriction at the anastomotic ring. An intraluminal end to end anastomotic stapler includes an expanding head and anvil designed to fire an anastomotic ring having an inner diameter at least equal to the nominal inner diameter of the remaining lumen sections. An extraluminal end to end lumen stapler is described attaching the lumen sections with an exterior flange type connection having anastomotic rings with a diameter larger than the inner diameter of the lumen sections whereby the anastomotic site has a diameter at least as great as the adjacent lumen sections

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of and claims the benefit of U.S.patent application Ser. No. 10/910,777, filed on Aug. 2, 2004 andentitled “Luminal Anastomotic Device”, now U.S. Pat. No. 7,080,769 andwhich published Mar. 31, 2005 as Publication number 2005-0067454. U.S.patent application Ser. No. 10/910,777 is a continuation of and claimsthe benefit of U.S. patent application Ser. No. 10/114,421, filed onApr. 2, 2002 and entitled “Luminal Anastomotic Device and Method”, nowU.S. Pat. No. 6,769,590 and which published Dec. 12, 2002 as Publicationnumber 2002-0185517 and which claimed the benefit of Provisional PatentApplication Ser. No. 60/280,785 entitled, “Luminal Anastomotic Deviceand Method” filed Apr. 2, 2001. These patents and associated patentpublications are incorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to surgical anastomotic stapling devices.More particularly, the present invention relates to end to endanastomotic surgical staplers avoiding minimal constrictive area at theanastomosis site.

2. Background Information

Surgical staplers have been developed to assist and improve a widevariety of surgical procedures. Surgical staplers provide precision inthe placement of staples as well as decrease the time of given surgicalprocedures. A wide variety of surgical staplers have been developed forvascular, gastric, esophageal and intestinal surgery, to name but a few.These known staplers are often used in anastomosis procedures. Inperforming surgical anastomotic stapling, generally the two pieces oflumen are attached by a ring of staples with a closed loop stapler. Theanastomosis of the lumen may be performed in a side to side, side to endor end to end manner which describes the relative orientation of thelumen sections.

The surgical staplers for performing end to end anastomosis aregenerally intraluminal surgical staplers that fire a pair of staggeredrings of staples. These types of surgical staplers are often referred toas EEA's, which stands for “End to End Anastomosis”. During thisprocedure, a circular knife blade is used to separate tissue which isheld within the circular ring. The separated tissue is then removed withthe stapler so that a circular opening within the lumen is completedalong the surgical stapling line.

In performing these surgical procedures with EEA's it has becomedesirable to separate the anvil on which the staplers are clinched fromthe stapling head portion from which the staples are expelled. It hasbeen typical in the past that the stapling head is attached to the anviland the tissue is secured through a “purse stringed” gathering oftissue.

Generally, the tissue stapled together with an EEA leaves a smalleropening than the original lumen into which the anvil and stapler headwere inserted. Frequently, it is desirable to provide an anvil which canbe collapsed to introduce the anvil into the body through a relativelysmall incision. An example of a surgical stapler having a variablediameter anvil is illustrated in U.S. Pat. No. 4,505,414 disclosing ananvil, integral with a surgical stapler, which can be collapsed andinserted through a small incision in a patient's body and expandedoutwardly after placement inside the patients body to staple the wall ofan organ to the abdominal wall or an external tissue layer of thepatient's body. The anvil is not detachable from the stapler and thuscannot provide a continuous stapler line, but rather applies a broken,discontinuous line to “tack” the tissue in a circular line. This patentalso does not provide an anvil which can be placed remotely within thebody for subsequent attachment to a stapler head.

Other examples of anvils which are capable of collapsing to a reduceddiameter after stapling to facilitate removal from the body are shown inU.S. Pat. Nos. 4,752,024; 4,893,622; 4,700,703 and 4,903,697. Theseanvils are introduced into the body through a relatively large incision.

U.S. Pat. No. 5,239,639 also shows a collapsible anvil assembly andapplicator instrument for a surgical stapler apparatus. U.S. Pat. No.6,503,259 is relevant to the present invention in that it discloses asurgical anastomotic fastener array (10 in the '259 patent) comprising aplurality of fasteners (11 of the '259 patent) each having a tissuepiercing element (12 of the '259 patent), wherein the fasteners arealigned in an annular array of a first diameter at least prior toanastomosis and are designed to expand to form an annular array of asecond larger diameter and then contract as needed after anastomosis.The '259 patent is addressing the same broad concern of the resultinganastomotic ring, but the earliest filing date of the '259 patent is,however, not earlier than the conception date of the present invention.

The retractable anvil EEA's discussed above do not address thefundamental problem of the constrictive point formed after luminalanastomosis. These prior art devices simply address the problem of postoperative tool removal.

It is the object of the present invention to avoid the drawbacks of theprior art by avoiding the minimal constriction formed at luminalanastomotic sites using anastomotic staplers (i.e., EEA's). It is afurther object of the present invention to provide anastomotic staplerswhich are easy to manufacture and utilize. A further object of thepresent invention is to provide both intraluminal anastomotic end to endstaplers and extraluminal anastomotic end to end staplers.

SUMMARY OF THE INVENTION

The above objects are achieved with the anastomotic device according tothe present invention. The anastomotic device according to the presentinvention is a surgical stapler that will form an anastomosis betweenexisting lumen sections in an end to end alignment forming theanastomosis site with a minimal diameter generally equal to or greaterthan the normal inner diameter of the anastomized lumen sections, withthe lumen sections in a normal relaxed condition. The anastomotic deviceof the present invention will preferably utilize conventional staplesformed in a pair of offset annular arrays of staples to couple the endof a first lumen section to the end of a second lumen section.

A first embodiment of the present invention forms the anastomotic deviceas an intraluminal end to end surgical stapler. The intraluminalsurgical stapler fires staples, or other fastening devices, from astapling head to an adjacent anvil. In accordance with the presentinvention, both the head and the anvil can be moved from a retractedposition having a first relative diameter to an expanded position of asecond larger diameter. The expansion of both the head and the anvilallows the anastomotic device to be positioned in the lumen to beattached with minimal interference and then expanded to an enlargedfiring position, wherein when fired the anastomotic ring formed by thearray of staples is positioned at a diameter preferably at least aslarge as the minimum diameter of the adjacent lumen sections. Afterfiring, the head and anvil of the stapler of present invention can bothbe retracted to allow for easy withdrawal of the stapler from theanastomized lumen.

In one embodiment of the present invention, the head will be formed of aplurality of wedge-shaped arc segments which move radially and align inan expanded position to form the annular head. The arc segments may bein the form of inner wedge-shaped segments moved by an actuator andouter segments guided by the inner wedge-shaped segments. Thewedge-shaped segments may be moved into the expanded or retractedpositions by being coupled to the actuator in the form of axiallymovable wedges controlled by the user.

Another embodiment of the present invention will form the annular headas a plurality of arc segments that slide together with the segmentsformed in an overlapped position in the retracted state and rotate intocontracted and expanded positions. A further embodiment of the presentinvention will hinge various arc segments together to allow the segmentsto pivot between a retracted position of a minimal diameter and anexpanded position forming the annular head ready for firing.

Each individual arc segment of the head portion will include stapleswhich combine to form the array of staples in the expanded position. Onekey aspect of the present invention is that each arc segment has aseparate firing mechanism as well as a knife actuating mechanismindependently associated with each segment. Each segment will have anarcuate knife portion which will combine and overlap with the knifeportions of adjacent segments to form a continuous annular knifearrangement when the head is in the expanded position. In this manner,the knife portions and staples of each individual segment will combineto form the dual stapling array and annular knife well-known to thoseskilled in the art (except of a larger diameter relative to the body ofthe stapler). The firing mechanism of each individual segment isadditionally coupled to the controller of the stapler in a manner whichaccommodates movement of the individual segments between the retractedand expanded positions. This construction of the segments allows for thesegments to be formed in the hinged arrangements, spirally attachedarrangements or wedge arrangements discussed above. Many other possiblerelatively movable combinations may be constructed with the individualsegment construction of the stapler of the present invention.

Another aspect of the present invention is to form an external end toend anastomotic surgical stapler. The external stapler according to thepresent invention is designed to clamp around lumen sections to beattached. The extraluminal stapler according to the present invention isdesigned to form an anastomizing ring of sutures external to theconnected lumen sections. The external stapler according to the presentinvention forms a pair of annular arrays of staples around an outwardlyextending flange of the connected lumen sections.

In one embodiment according to the present invention, the extraluminalstapler is formed of two opposed stapler units with each stapler unitformed of two halves hinged together. The extraluminal stapler willinclude a mechanism for pulling the lumen to be attached around thestapling face of each stapling unit. The extraluminal stapler accordingto the present invention will additionally include a mechanism foraligning the stapling head and anvil portions of the opposed staplingunits with each other as well as a firing mechanism for firing thearrays of staples in the stapling units. One embodiment of the presentinvention will form each stapling unit as an anvil and head portionhinged together which couples with an adjacent hinged anvil and headportion of the opposed stapling unit.

The present invention would be particularly applicable for bowelresections as will be understood by those of ordinary skill in the art,but is not intended to be limited thereto. It can be used in many otherapplications such as, but not limited to, vascular anastomosis,gastrointestinal anastomosis, esophageal anastomosis and essentially anyhollow lumen within the body. Further, the specific embodiments of theinvention include a variety of unique features that can be incorporatedseparately or in various combinations into other stapling and surgicaldevices for improving those devices.

One advantage of the present invention is a minimally invasive surgicalstapler that will assist in stapler placement because the diameter ofthe stapler (i.e. the largest diameter portion, specifically the headand anvil of the stapler) is smaller during insertion and retractionthan at firing.

Another advantage of the present invention is having a closed loop EEAstapler with the trimming knife formed by individual knife segments.This feature of the present invention may be utilized for firing theknife segments individually, or in a given sequence, or simultaneously(as utilized in the illustrated embodiments of the present invention.

Another feature of the present invention is the accommodation ofmultiple anvil and multiple head controls in a surgical stapler. Onepresent illustrated embodiments provide separate controls forexpansion/retraction of the anvil and for axial movement of the anvil.This illustrated embodiment further provides independent control forexpansion/retraction of the head and for firing of the knife blade andstaples. This system of multiple independent control may be modified toperform a variety of separate control features for the anvil and headportions of an EEA stapler.

Another feature of the present invention is the provision of an EEAstapler with a staple and knife firing mechanism that accommodatesrelative motion of the head portion containing the staples and thefiring mechanism.

Another feature of the present invention is the provision of analignment mechanism that aligns and locks the anvil and head portiontogether prior to the firing of the staples or the knife.

Another feature of the present invention is the provision of a closedloop surgical stapler for end to end anastomosis in which the staplerextends around the outside of the lumen portions being anastomised.

These and other advantages of the present invention will be clarified inreviewing the detailed description of the preferred embodiments takentogether with the attached figures wherein like reference numeralsrepresent like elements throughout.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 a is a side view, partially in section, of a pair of lumensections anastomized using existing intraluminal anastomotic staplers;

FIG. 1 b is a side view, partially in section, of a pair of lumensections anastomized with an anastomotic stapler according to a firstembodiment of the present invention;

FIG. 1 c is a side view, partially in section, of a pair of lumensections anastomized using an anastomotic stapler according to a secondembodiment of the present invention;

FIG. 2 a is a schematic plan view of an intraluminal end to endanastomotic stapling head according to the first embodiment of thepresent invention with the head in the expanded, firing position;

FIG. 2 b schematically illustrates the head illustrated in FIG. 2 a inthe retracted position;

FIG. 3 a schematically illustrates an expandable anvil associated withthe anastomotic stapler having the expandable head illustrated in FIGS.2 a and 2 b;

FIG. 3 b schematically illustrates the anvil portion of FIG. 3 a in aretracted position;

FIG. 4 a schematically illustrates a spirally retracted and expandablehead for an intraluminal end to end surgical stapler according to asecond embodiment of the present invention;

FIG. 4 b schematically illustrates a hinged expandable and retractablehead for an intraluminal end to end surgical stapler according to athird embodiment of the present invention;

FIG. 5 a is a plan view of an individual outer head segment of the headillustrated in FIGS. 2 a and 2 b;

FIG. 5 b is a radially inner side view of the head segment illustratedin FIG. 5 a;

FIG. 5 c is a sectional view of the head segment illustrated in FIG. 5 ataken along line Vc-Vc;

FIG. 5 d is a sectional view of the head segment illustrated in FIG. 5 ataken along line Vd-Vd;

FIG. 5 e is a top plan view of an inner head segment illustrated inFIGS. 2 a and 2 b;

FIG. 5 f is a radially inner side view of the inner head segmentillustrated in FIG. 5 e;

FIG. 5 g is a sectional view of the inner head segment shown in FIG. 5 etaken along line Vg-Vg;

FIG. 6 a is a perspective view of an intraluminal anastomotic surgicalstapler utilizing the expandible head illustrated in FIGS. 2 a and 2 band the expandible anvil illustrated in FIGS. 3 a and 3 b;

FIG. 6 b is a partial section of a portion of the stapler illustrated inFIG. 6 a taken along line VIb-VIb in FIG. 6 a;

FIG. 6 c is a cross-sectional view of the stapler illustrated in FIG. 6b taken along line VIc-VIc;

FIG. 6 d is a cross-sectional view of the stapler illustrated in FIG. 6b taken along line VId-VId;

FIG. 6 e is a side view partially in section of a distal end of thestapler illustrated in FIG. 6 a;

FIG. 7 a is a perspective view partially in section of a first half ofan extraluminal end to end surgical stapler according to the presentinvention;

FIG. 7 b is a side view of the complete extraluminal surgical staplerillustrated in FIG. 7 a;

FIG. 8 a is a perspective view of a lumen section to be anastomizedutilizing flexible clips associated with the surgical staplerillustrated in FIGS. 7 a and 7 b;

FIG. 8 b is an end view of the lumen and clips illustrated in FIG. 8 a;

FIG. 8 c is a side view of the clips utilized in FIGS. 8 a and 8 b inthe open position;

FIG. 8 d is a plan view with the clips in the open position of the clipillustrated in FIG. 8 c;

FIG. 8 e is a cross-section of the clips illustrated in FIGS. 8 c and 8d with the clip in a partially closed position;

FIG. 9 is a sectional schematic view of an alignment mechanism for usein a stapler of the present invention;

FIG. 10 is a sectional schematic view of a motion accommodationmechanism for the anvil expansion mechanism of a stapler according tothe present invention; and

FIG. 11 is a schematic plan view of a lock and release transmission foran anvil stem and an anvil expansion rod of a stapler according to thepresent invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The objects and advantages of the present invention can be bestclarified in reviewing the surgical results illustrated in FIGS. 1 a, 1b and 1 c with the prior art surgical staplers (FIG. 1 a) and variousembodiments of surgical staplers (FIGS. 1 b and 1 c) of the presentinvention, respectively. FIG. 1 a illustrates lumen sections 10 and 12anastomized with a conventional intraluminal anastomotic stapler (i.e.an EEA). The first lumen section 10 and second lumen section 12 willhave a nominal diameter d.sub.1. With existing end to end anastomoticstaplers, the anastomosis site, sometimes referred to as an anastomosisring, formed by an array of staples 14 will have a smaller diameterd.sub.2 than the nominal luminal diameter d.sub.1. In addition to theconstrictive point formed by the smaller diameter d.sub.2, with theexistence of (1) the array of staples 14, (2) the additional tissueformed by the coupled lumen sections at the anastomosis site, and (3)the scar tissue forming around the anastomotic ring, this constrictureor constriction will have greater rigidity, i.e., less flexibility, thanthe associated lumen tissue. As discussed above, the object of thepresent invention is to avoid this constrictive point and the possibledetrimental effects associated therewith. Of course, the detrimentaleffects associated with a more rigid constricture in an anastomizedlumen would depend on the particular lumen which is coupled together.However, whether connecting together a bowel in vascular anastomosis, orconnecting any lumen within the body such constrictures are universallyundesirable.

FIG. 1 b illustrates the anastomosis of lumen sections 10 and 12 with asurgical stapler 100 according to a first embodiment of the presentinvention. The anastomotic stapler 100 of the invention associated withthe results shown in FIG. 1 b is described in detail in FIGS. 2 a and 2b, 3 a and 3 b, 4 a and 4 b, 5 a-5 g, and 6 a-6 e. As illustrated inFIG. 1 b, the anastomotic ring or suture site formed by the array ofstaples 14 has an inner diameter d.sub.3, which is relatively largerthan the diameter d.sub.2 associated with conventional staplers. Thediameter d.sub.3 is preferable formed at least as great as diameterd.sub.1 of the adjacent lumen sections. In this manner, the detrimentaleffects of the constricture site can be minimized. It should beappreciated that the inner area of the anastomized lumen is associatedwith the square of the diameter such that minimal improvements in thediameter of d.sub.3 over d.sub.2 of the prior art will result insubstantial increases in the area of the lumen. It is preferred that inthe present invention, the diameter d.sub.3 at the anastomotic ring beat least as great, or greater than the nominal diameter d.sub.1 of theassociated lumens to avoid any problems with constricture. The relativeincrease or expansion of the anastomotic ring possible with the deviceaccording to the present invention will be associated with the tissueflexibility of the lumen sections for which the particular stapler isdesigned. For example, tissue forming a bowel (relatively flexible) andtissue forming vascular lumens (less flexible compared to the bowel)would accommodate different relative dimensions for d.sub.3 compared tod.sub.1 at the anastomotic site. However, the general operative conceptsof an intraluminal bowel stapler according to the present invention isthe same as an intraluminal vascular stapler according to the presentinvention.

FIG. 1 c illustrates an end to end anastomosis of two lumens 10 and 12with an array of staples 14 utilizing an extraluminal surgical stapleraccording to a second embodiment of the present invention. The stapleraccording to the second embodiment of the present invention forms anouter anastomotic ring with the array of staples having a diametergreater than d.sub.1, the normal diameter of the lumen, such that theanastomosis site forms no constricture. The relative positioning of thearray of staples 14 will again depend on the particular lumen beinganastomized. Examples of the stapler forming this anastomosis areillustrated in FIGS. 7 a, 7 b, and 8 a-8 e below.

FIGS. 2 a and 2 b schematically illustrate an expandable head 90 for theintraluminal anastomotic stapler 100 according a first embodiment of thepresent invention. The expandable head 90 is formed of a plurality ofarc segments which interconnect in an outer firing position to form theannular expanded head 90 as shown in FIG. 2 a. The individual segmentsshown in the embodiment illustrated in FIGS. 2 a and 2 b comprise outerwedge-shaped segments 102 and inner wedge-shaped segments 104. The innersegments 104 are moved radially inwardly and outwardly by individuallyassociated wedge elements 106. The side wedge-shaped engaging surfacesof the inner segments 104 will force the outer segments 102 into theexpanded condition. The inner segments 104 can be pinned to the outersegments 102 in a manner to be described later such that retraction ofthe inner segments 104 to the retracted position shown in FIG. 2 b willalso pull the outer segments 102 toward the retracted position.

The structure of the individual segments 102, 104 be discussed later ingreater detail. Generally speaking, each segment 102, 104 includes aplurality of staple receiving slots 108 in a staggered annular arrayconsisting of both an outer ring and an inner ring of staples receivingslots 108. As clearly evident in the figures, it is an important aspectof the present invention that the division between adjacent segments102, 104 needs to be accomplished between the staple receiving slots108. As can be seen in the figures, in the expanded position, thesegments 102, 104 combine to form a standard annular array of staples 14in an offsetting overlapping arrangement. Additionally, each segment102, 104 includes, at a radial inner side thereof, with knife portions110 which combine in the expanded position to form an annular knifewhich provides a trimmed inner edge to the anastomized lumen as isconventional. In order to ensure a complete annular knife in the firingposition, and therefore a complete annular smooth cut to the lumen,knife portions 110 of the inner segments 104 overlap with the knifeportions of the adjacent outer segments 102 as generally illustrated inthe figures. As can be seen in FIGS. 2 a and 2 b, the wedge-shapedinteracting arc segments 102, 104 of the head 90 will allow it to bemoved between retracted and expanded positions. It should be evidentthat the present invention is not intended to be limited to the specificnumber of segments illustrated in FIGS. 2 a and 2 b. A minimization ofthe diameter in the retracted position can be obtained with as little asthree inner wedge-shaped segments 104 spaced about the periphery of thehead 90. The number, positioning and specific shape of the segments 102,104 can be changed as desired in order to allow for the desired degreeof expansion. Other factors affecting the number and shape of theindividual segments 102, 104 will be the number and length of thespecific staples 14 utilized in the inner and outer rings. All of thesefactors can be considered in designing a specific expanding head 90which expands to the degree desired.

FIGS. 3 a and 3 b illustrate the expanding anvil 120 utilized with thestapler 100 according to the present invention. These figures illustratethat the anvil 120 is formed of inner segments 122 and outer segments124 similar to the inner segments 104 and outer segments 102 of the head90. The anvil 120 in the expanded position forms an annular ring withconventional staple engaging grooves 126 which will correspond to thestaple receiving slots 108 of the head 90 for cinching the fired staples14 as known in the art. The inner and outer segments 122, 124 can bepinned together and the inner segments 122 can be moved by a wedge 128similar to the mechanism for the head 90. The anvil 120 construction issignificantly simpler than the head 90 construction for a variety ofreasons. First, the anvil 120 construction is not limited to forming thestaple engaging grooves 126 entirely on one segment 122 or 124. Theseexpanding anvil segments 122, 124 can be formed essentially in anyposition even dividing a staple receiving groove 126. This providessignificantly greater flexibility in deciding where to put the inner andouter segments 122, 124. An additional aspect to making the anvil 120significantly easier to design and operate is that there is no knife orstaple firing mechanisms which needs to be incorporated into theexpanding and retracting anvil 120. In fact, the prior art illustratesthat expanding anvils have been well-known in the art, and many of theseconstructions can also be incorporated into the design of the presentinvention. For the sake of simplicity, however, the design of the anvil120 is essentially the same as the design of the expanding head 90illustrated in FIGS. 2 a and 2 b.

FIGS. 4 a and 4 b are intended to illustrate alternative expanding headmechanisms according to the present invention. FIG. 4 a illustrates anexpanding head 140 according to one embodiment of the present inventionin which the head 140 is formed of individual segments 142 which canslide past each other in an overlapping arrangement to contract in aspiral fashion as illustrated by the arrows. In place of an actuatingwedge, the actuating mechanism may be a rotating cam type operator,although a variety of segment 142 moving mechanisms can be envisioned.

FIG. 4 b illustrates yet another embodiment for an expanding head 150for a stapler 100 of the present invention in which individual segments152 of the head 150 are hinged together by hinges 154 to move betweenexpanded and contracted positions. This embodiment illustrates threehinges 154 and one open connection which can have these segments 152snap together to form the continuous ring. The number of individualsegments 152 may be selected as desired. The hinges 154 may includespring-biasing to help move the segment 152 to either the expanded orretracted positions. A mechanical actuator linearly moving along thelength of the stapler 100 would be used to move the segments 152.

FIGS. 5 a-5 g illustrate the details of the individual arc segments 102,104 forming the expandable head 90 illustrated in FIGS. 2 a and 2 b. Thesegments 102, 104 are discussed in detail and illustrated associatedwith the specific expanding head 90 illustrated in FIGS. 2 a and 2 b.However, the general concepts of these individual segments 102, 104 canbe easily extrapolated for many different embodiments, such as thoseillustrated in FIGS. 4 a and 4 b. The key features of the arc segments102, 104 for the expanding head 90 according to the present invention isthat the individual segments 102, 104 have independent firing mechanismsfor the staples 14 and the knife portions 110 that are associated withthat segment 102, 104. Additionally, the firing mechanism accommodatesthe relative motion of the segments 102, 104 between the retracted andexpanded positions. As will be evident in the description of FIGS. 5 a-5g, these components utilized in the segments 102, 104 of the presentinvention can be utilized in the expanding heads 140 and 150 illustratedin FIGS. 4 a and 4 b as well as a wide variety of other configurationsfor an expanding head having separate segments the user may contemplate.

FIG. 5 a illustrates a plan view of the outer segment 102 of theexpanding head 90 illustrated in FIG. 2 a. The outer segment 102includes a plurality of slots 108 for receiving staples 14 therein asshown in FIGS. 5 c and 5 d. On the radial inner side of the segment 102is a groove 160 extending across the entire segment 102. The arcuateknife portion 110 is positioned in the groove 160. The knife portion 110and staples 14 are all fired through a common firing mechanism which canbe best seen in FIGS. 5 c and 5 d. Essentially, a base plate 162 ispositioned in a recess 164 extending along the length of the segment102. The base plate 162 includes a plurality of pusher bars 166extending into the individual staple receiving slots 108 for supportingand firing the staples 14. As illustrated in FIG. 5 c, the base plate162 is positioned in the recess 164 with enough room for movement(longitudinally of the stapler 100) for allowing the firing of thestaples 14 and the knife portion 110. Additionally, the knife portion110 is attached to the base plate 162 through a series of L-shaped arms168 at spaced locations along the base plate 162. The L-shaped arms 168extend through slots 170 in the segment 102. The base plate 162 issecured to an actuation rod 172 at the bottom thereof for moving thebase plate 162 in the segment 102 for firing of the staples 14 andactuation of the individual knife portion 110.

As discussed previously, the individual knife portions of the varioussegments 102, 104 will overlap to assure that a complete annular circleis formed and cut by the combined knife portions 110. In order to easilyaccommodate the overlapping of the outer edges of the segments 102 nearthe groove 160 are cut out at recess 174 to allow the overlappingportions of the knife portions 110 of the inner segments 104 discussedbelow to easily overlap the knife portions 110 of the outer segments 102when the inner segments 104 are pushed into position. Additionally, theouter segments 102 are provided with pin receiving grooves 176 forpinning the outer segments 102 to the inner segments 104. The grooves176 will allow the inner segments 104 to follow a defined path ofmovement during the expansion and contraction as well as pull the outersegments 102 towards the retracted position when the inner segment pin178 reaches the radially inner extent of the groove 176 during theretraction of the expandable head 90.

In view of the complex shape, it is expected that the segments 102, 104may most easily be formed of an injection molded plastic design,however, any construction technique and material is contemplated.

FIG. 5 e illustrates a plan view of the inner segments 104 for theexpandable head 90 in FIGS. 2 a and 2 b. The inner segment 104additionally includes staple receiving slots 108 in two annular arrayssimilar to the staple receiving slots 108 formed in the outer segment102. Furthermore, the inner segment 104 includes a groove 160 on theradially inner edge thereof receiving an annular knife portion. Asillustrated in FIGS. 5 e and 5 f, the annular knife portion 110 of theinner segment 104 extends beyond the edges of the segment 104 to provideon overlapping blade section which would be received in the recess 174of the outer segments 102 shown in FIG. 5 a. As discussed above, thisconstruction ensures the overlapping of the knife portions 110 to form acomplete annular knife blade ring 178. The inner segments 102 willadditionally include the pins on the sides thereof for engaging withgrooves 160 formed on the sides of the outer segment 102 thereby keyingthe segments 102, 104 together.

As shown in FIG. 5 g, the inner segment 104 will additionally include afiring mechanism comprised of a base plate 162 with staple projectionsextending vertically upward into the staple receiving slots 108. Thebase plate 162 will also be coupled to the knife portion 110 at spacedlocations by L-shaped arms (not shown) extending through slots (notshown) in the same manner as in the outer segments 102 disclosed abovein FIGS. 5 a and 5 c.

The inner segments 104 additionally include a beveled T-shaped slot 180receiving a wedge rod 182 and wedge element 106 therein which operatesto move the inner segments 104 and the outer segments 102 for expandingand contracting the head 90. The T-shaped slot 180 is intended to bejust one configuration for tying the movement of the segments 102, 104,both in the expansion and retraction mode, to the movement of thecontrolling wedge rod 182 and attached wedge element 106. Othermechanical connections and actuation mechanisms are contemplated withinthe scope of the present invention. However, it is believed that thesimple mechanical coupling of the components as illustrated is generallypreferable to a spring-biasing operation which may not be successful ifthe forces of the operating spring do not overcome friction or otherforces in the stapling environment. Consequently, it is believed thatthe operating mechanism of the present invention provides a mechanicallysimple and highly reliable method for actuating and moving theexpandable head 90.

It will be appreciated that the specific construction of the inner andouter segments 102, 104 are not limited to the shapes illustrated. Thegeneral construction can be expanded to any segment shape such as thoseillustrated in FIGS. 4 a, 4 b or many other shapes that can becontemplated for forming an expandable head 90 for a stapler 100.

FIGS. 6 a-6 e illustrate the details of an intraluminal anastomoticstapler 100 with an expanding head 90 illustrated in FIGS. 2 a and 2 bas well as an expanding anvil 120 illustrated in FIGS. 3 a and 3 b. Thestapler 100 looks essentially like a conventional EEA stapler having anelongated body 190 of generally circular cross-section further includingthe expanding head 90 and anvil 120 at a distal end thereof. Theexpanding anvil 120 will have a length slightly longer than an anvil ofa conventional EEA to accommodate the expanding anvil mechanism. At theopposite end of the body 190, the stapler 100 will have generallyconventionally shaped controls 192, 194 for advancing and retracting theanvil 120 relative to the head 90 and for firing of the staples 14.Specifically, a rotatable controller 192 is utilized for expanding andcontracting the anvil 120 and clamping the lumen sections 10 and 12together and a pair of pivoted firing grips 194 are utilized for firingthe staples 14. Additionally, the stapler 100 may include a known safetyrelease (not shown) which does not allow the staples 14 to be firedunless the anvil 120 is in an acceptable proximity of the head 90. Thissafety mechanism may also be tied to the expanding mechanism, to bedescribed, such that the firing of the staples 14 would not be possibleunless the head 90 and anvil 120 are also expanded to the appropriateexpanded, firing positions.

With regard to the expansion control, a pair of finger grip controllers196 extend from opposite sides of the housing or body 190 extending froma Z-shaped slot 198. When desired to expand, the user can grip one orboth expansion controllers 196, pivot them slightly out of the retractedposition (i.e., one leg of the z-shaped slot 198) moving axially alongthe length of the housing in a axial portion of the Z-shaped slot 198and then when fully expanded move the controllers 196 into the upper legof the Z-shaped slot 198 to hold the anvil 120 and head 90 in the fullyexpanded position. After firing, the process can be reversed forretracting both the anvil 120 and head 90. It will be appreciated thatwithin this construction, the outer diameter of the body 190 can beformed approximately equal with the diameter d.sub.1 of the lumensections 10 and 12 to be anastomized. It will be understood that theexpanded head 90 and anvil 120 will expand the lumen sections to astretched condition such that the anastomized ring will be formed at adiameter d.sub.3, preferably at least as great as the normal unstretcheddiameter d.sub.1 of the lumen sections 10 and 12 to be anastomized.

FIG. 6 b is a sectional view of the controlling portion taken along tworadial sections offset 90 degrees to best illustrate the expansion,clamping and firing controls (196, 192, 194) of the present invention.

As shown in FIGS. 6 b and 6 c, for at least a portion of the housing orbody 190, the operating mechanisms are formed of a series of concentricindependently operated sleeves for controlling the various functions ofthe stapler 100 of the present invention. It should be understood thatthe sleeves are intended for limited axial motion along the length ofthe body 190 and may be formed of either a rigid or slightly flexiblematerial. In other words, the body 190 may have a certain curvaturealong its length, as is known in the art, and the operating mechanismcan be made of a material to accommodate such curvature.

Beginning next to the annular housing or body 190 is a firing ring 200which is utilized for actuating the firing mechanisms in the individualhead segments 102, 104. At one end of the axially movable firing ring200, a series of the firing or actuation rods 172 are attached whichextend from the firing ring 200 to each individual base plate 162 ofeach individual segment 102, 104. The firing rods 172 can be pivotallyattached to the firing ring 200 and segments 102, 104 or the rods 172can be formed sufficiently flexible to accommodate the outward movementof the associated segments 102, 104. The opposite end of the firing ring200 includes a pair of L-shaped legs 202, only one of which is shown inFIG. 6 b, attached to the individual firing grips 194. As can be easilyunderstood by viewing FIG. 6 b, when the firing grips 194 are pulled,the legs 202 in the firing ring 200 will be moved axially along the body190 moving the rods 172, axially along the body thereby pushing theassociated base plates 162, firing the individual staples 14 andactuating the individual knife portions 110. It should be appreciated bythose of ordinary skill in the art that a wide variety of changes to thefiring mechanism can be envisioned. For example, a pull trigger couldeasily replace the firing grips 194. The firing grips 194 areillustrated since this represents a known acceptable operatingmechanism. As discussed above, a safety latch mechanism can beincorporated, if desired, to avoid premature firing of the staples 14.The construction of such safety devices is certainly known to those ofordinary skill in the art.

Radially adjacent the firing ring 200 is an independently movable wedgering 210 for moving the head segments 102, 104 as will be discussed. Ata forward end of the wedge ring 210 are a series of the longitudinallyextending wedge rods 182. The wedge rods 182 and wedge elements 206combined have a beveled T-shape which is engaged in the T-shaped slot180 of the inner segments 104 for radially moving the segments 102, 104as the associated wedge rod 182 and wedge element 106 are movedlongitudinally back and forth along the body 190. As illustrated in FIG.6 d, there is one wedge element 106 associated with each inner segment104. On the opposite end of the wedge ring 210 the wedge ring 210 issecured to the pair of opposite extending controllers 196, only one ofwhich is shown in FIG. 6 b, by an arm 212 or a linkage, again only oneof which is shown in FIG. 6 b. As can be most apparent in FIG. 6 b,longitudinal movement of the controller 196 will move the connectinglinkage arm 212, the wedge ring 210 and the associated wedge rod 182 andwedge element 106 for radially moving the head segments 102, 104 betweenthe fully extended position shown in FIG. 2 a and the fully retractedposition illustrated in FIG. 2 b.

Radially adjacent the wedge ring 210 is an anvil stem rod 220 movinglinearly in the body 190 for moving the anvil 120 into and out of aclamping position relative to the head 90. At one end of the anvil stemrod 220 is a generally disc-shaped actuator 222 threadedly engaginginner threads 224 on the rotatable controller 192. The rotatablecontroller 192 is attached to the housing in a manner that allows forrotation such that rotation of the controller 192 will axially move theactuator 222 and the anvil stem rod 220 for moving the anvil 120essentially in a conventional fashion. As shown in FIG. 6 e, a distalend of the anvil stem rod 220 has a snap fit connection 226 with anannular anvil connector 228 allowing the anvil 120 to be released fromthe body as known in the art.

Finally, returning to FIG. 6 b, the innermost control mechanism is ananvil expanding rod 230 axially movable in the body 90 and adapted forexpanding the anvil segments 102, 104 between the retracted and expandedpositions. The control end of the anvil rod 230 is connected to theexpanding controller 196 through a pivoting linkage 232 and a connectingarm 234. This mechanism allows the axial movement of the controller 196to be associated with an opposite movement of the expanding anvil rod230. A distal end of the expanding anvil rod 230 includes a connector236 having a bayonet type connection with an anvil wedge rod 238 asshown in FIG. 6 e. The anvil wedge rod 238 is associated with four wedgerod elements 240 which support the wedges 128 received in grooves in theinner anvil expanding segments 122 as shown in FIG. 6 e. It will beappreciated that in the illustrated embodiment the expanding anvil rod230 and the anvil wedge rod 238 will only be in a secure fittingrelationship when the anvil 120 is appropriately clamped against thehead 90. With this construction, it may be helpful to have the anvilwedge rod 238 and the associated segments 102, 104 be spring-biased tothe retracted position so that there is a retracting biasing force whenthe expanding anvil rod 230 is not engaged with the anvil wedge rod 238.

It should be appreciated that other constructions are certainlyanticipated, such as having the wedge rod 238 and the expanding anvilrod 230 always coupled when the anvil stem rod 220 and annular anvilconnector 228 are connected. In this modification, the anvil expandingrod 230 and the anvil stem rod 220 will need to be moved together. Theanvil stem rod 220 is moved relative to the body 190 by rotation of thecontroller 192. In this modification, the movement of the anvil stem rod220 can be accommodated by moving the pivoting linkage 232 and theexpanding anvil rod 230 with the anvil stem rod 220 and having a lostmotion or motion accommodating mechanism be added to the connecting arm234 to accommodate the change in relative position. One simple exampleof such a mechanism is illustrated in FIGS. 10 and 11 and essentiallyincludes forming the connecting arm 234 as a telescoping rod havingfirst and second portions 234A and 234B, respectively. The first andsecond portions 234A and 234B are releasably pinned together with aspring-biased release pin 235 being released by a button 237 (upon whichthe spring 241 acts) on the body 190 when the controller 192 is desiredto be rotated. With such a spring-biased release button 237 and pin 235,the pin 235 is automatically reinserted to connect the first and secondtelescoping portions 234A and 234B of the arm 234 such that theconnecting arm 234 would accommodate the changed length. This embodimentadditionally illustrates the use of a releasable lock or transmissionbetween the expanding anvil rod 230 and the anvil stem rod 220. Thereleasable transmission or lock is in the form of a mating pin 247extending from the lower end of the controller 196. The mating pin 247extends into generally identically shaped slots 249 formed in both theexpanding anvil rod 230 and the anvil stem rod 220. As shown in FIG. 11the edges of the slot 249 include mating surfaces that will engage andmechanically lock with the mating pin 247. The slots are designed suchthat the locking or mating will occur when the controller 196 is in thefar left or right radial positions in the z-shaped slot (e.g. when thecontroller 196 is in the top or bottom leg portions of the z shapedslot) as shown in positions A and B in FIG. 11. When the controller 196is in the center of the Z-shaped slot for longitudinal movement the pin247 will be disengaged from the edges of the slot 249 as shown inposition C allowing for the relative movement between the expandinganvil rod 230 and the anvil stem rod 220. It will be understood thatthis transmission will require modification of the Z-shaped slot toaccommodate movement of the controller due to axial movement of theanvil, such as increasing the width of the bottom leg of the z in the zshaped slot. This will additionally provide a visual indicator of therelative axial position of the stem prior to expansion of the anvil.This embodiment could utilize the motion accommodating mechanism withoutthe mechanical lock or transmission or the mechanical lock may be usedin other EEA staplers as merely a stem position indicating mechanism.This embodiment is described to show the possibility of such aconstruction.

It should be appreciated that the intraluminal end to end anastomoticsurgical stapler 100 illustrated in FIG. 6 a is utilized in essentiallythe same manner as existing anastomotic devices with the addition of anexpansion and retraction step. Specifically, the stapler 100 is insertedinto one lumen section 10 or 12 to be anastomized with the anvil 120 andhead 90 either spaced apart or separated as desired by the user. Pursestrings attached to the lumen sections 10 and 12 can secure the segments10 and 12 around the anvil stem rod 220 and/or the anvil connector 228.The controller 196 is rotated to move the anvil 120 and head 90 into atleast an initial clamped position. At this point, the anvil 120 and head90 can be expanded to their extended positions and the staples 14 fired.Following firing, the staples 14 will form a enlarged anastomotic ringin the connected lumen sections 10 and 12 with the knife portions 110trimming off the inner diameter of the lumen sections 10 and 12 securedto the stapler 100 with the purse strings. The head 90 and anvil 120 canbe returned to the retracted position following the loosening of theclamped sections to allow the removal of the stapler 100.

The present invention operates essentially the same as existing end toend anastomotic devices with a significantly enlarged anastomosis ring.Specifically, the area at the anastomosis site is not decreased orreduced relative to the normal diameter of the anastomized sections.

FIGS. 7 a and 7 b illustrate an extraluminal end to end surgical stapler300 according to the present invention. The stapler 300 is intended toform anastomized lumen sections with an externally located anastomosisring relative to the lumen sections 10 and 12 illustrated in FIG. 1 c.

The stapler 300 according to the present invention includes two separatestapling units 310, with each stapling unit 310 generally including twosemi-circular sections 320, 322 hinged together by a hinge 324 extendingalong the length of the stapling unit. One stapling unit 310 is shown inFIG. 7 a. In a preferred embodiment of the present invention, one halfof each stapling unit 310 is formed as an anvil 320 havingconventionally positioned staple receiving grooves 126 staggeredthereon. The other semi-circular section 322 includes staples 14 andknife portion 110. The section 322 includes a series of staple receivingslots 108 for the staples 14 and a knife receiving groove 160 with thesemi-circular knife portion 110 received in the groove 160. The staples14 and knife portions 110 can be fired with a firing mechanismessentially the same as illustrated in the segments 102, 104 shown inFIGS. 5 a-5 g and therefore need not be discussed in detail. Onedifference is that the groove 160 is at the radially outer edge ratherthan on the radially inner edge. A firing rod 172 is attached to a baseplate 162, not shown, and can be directly connected through the housing333 to a linkage (not shown) associated with a firing trigger. The anviland head sections 320 and 322 shown in FIG. 7 a form one entire staplingunit 310 which forms one-half of the stapler 300. Another identicalstapling unit 310 would be attached in an opposite face to faceengagement (as shown in FIG. 7 b.). Each staple and knife firing headsection 322 is associated with the anvil section 320 of the oppositestapling unit 310, and vice versa. In other words, half of the staples14 of the complete anastomosis ring would be fired from one directionand the other half would be fired by the other stapling unit 310 in theopposite direction. Each stapling unit 310 includes alignment mechanismsfor combining with the opposite stapling unit 310 to complete the pairof the stapler 300. The alignment mechanisms can be easily constructedas a rod 330 extending from one section 320 which is received in alocking projection 332 formed on an opposite section 322. Thisconstruction will allow for easy alignment and attachment of the opposedstapling units 310.

Another key aspect of the present invention is a tissue holdingmechanism for pulling the tissue of the lumen sections 10 or 12 to beattached over the operating face of the stapling units 310. As will beappreciated by those of ordinary skill in the art, with such anextraluminal stapler 300 as disclosed, purse strings would not be veryefficient for positioning of the lumen sections 10 and 12 to be attachedon the stapler 300. To accomplish the positioning of the tissue, eachstapling unit 310 includes a plurality of tissue retraction members 340spaced around the periphery of each stapling unit 310. The tissueretraction members 340 are in the form of hooks 342 formed at the end ofcables 344 at circumferentially spaced locations. The cables 344 extendalong grooves formed in the body 190 back to a central controllingstructure 350 in the form of an axially movable stud 352 controlled by arotatable controller 354 journaled to the body 190. It should be evidentthat rotation of the controller 354 will axially move the stud 352allowing the cables 344 to be pulled out of the body 190 or retractedback into the body 190. With this construction, the hooks 342 can bepulled out and clipped onto the tissues at circumferentially spacedlocations around the lumen section 10 or 12 and the controller 354 canbe rotated to pull the hooks 342 and the associated tissue back untiltissue is surrounding the operating face of the one stapling unit 310.

It is anticipated that certain tissue may not be efficiently stretchedby a hook 342 attached at a single location (i.e., it may tear). Toeliminate this, the present invention contemplates flexible clips 360attached to the edge of the lumen sections 10 or 12 such as shown inFIGS. 8 a-8 e. The clips 360 are formed of a flexible hinged strip ofmaterial that can be secured around the edge of the resected lumensection. As shown in FIGS. 8 c-8 e, one simple construction for formingthe clips 360 is to provide a series of piercing projections 362 on oneside of the clip 360 which engage in snap fit receiving holes 364 on theopposite side of the clips 360 such that the clips 360 can be easilypress fit in position in a fast and secure manner. The clips 360 includea pair of eyelets 366 at spaced locations thereon with the eyelets 366forming a connection point for the associated hooks 342 of each staplingunit 310. The purpose of the clips 360 is to provide rigidity to the endof the lumen sections 10 or 12 being pulled and to distribute thestresses of pulling on the lumen section 10 or 12 across a greater areato avoid damaging the lumen section 10 or 12 and to easily pull thelumen section 10 or 12 into the extended position around the face of astapling unit 310.

In operation, the extraluminal stapler 300 illustrated in FIGS. 7 a and7 b operates as follows. After the resected portion of the lumen isremoved and the two remaining lumen sections 10 and 12 are to beattached, two separate stapling units 310 forming a combined stapler 300are attached with one unit 310 around each lumen section 10 or 12. Clips360 are positioned around the edge of each lumen section 10 or 12 asillustrated in FIG. 8 a and the controller 354 is rotated to release thecables 344 to allow enough slack to attach the hooks 342 to the eyelets366 of the clips 360. Once the eyelets 366 are attached to theassociated clips 360, the controller 354 can be rotated retract thecables 344, the hooks 342 and the associate clips 360 properlypositioning the lumen section 10 or 12 over the operating face of theassociated stapling unit 310. Following this, the stapler 300 of thepresent invention allows for visual inspection to assure that the lumenis properly positioned prior to snapping the two stapling units 310together using the alignment mechanisms formed by rod 330 and lockingprojection 332. The alignment mechanisms will preferably snap or holdthe two stapling units 310 together at a position sufficient for firing.It will be understood that an appropriate safety mechanism can beassociated so that the staples 14 could not be fired until the opposingstapling unit 310 is secured thereto. Once the opposing stapling unit310 is secured, the staplers 14 on both halves (i.e., in both staplingunits 310) can be fired performing the anastomosis. Following this, thetwo stapling units 310 can be removed from each other and eachindependently opened and the external stapler is removed from theanastomized lumen.

The use of an alignment mechanism for aligning the head and anvilportions of EEA staplers such as shown in staplers units 310 would alsobe beneficial for internal EEA staplers such as shown in FIGS. 6 a-e.The present invention contemplates an alignment mechanism 400 associatedwith such an EEA stapler as schematically shown in FIG. 9. The alignmentmechanism 400 essentially includes a plurality of locking pins 402associated with each head segment 102 and 104. The locking pins 402 arereceived in mating holes 404 on the associated anvil segments 122 or124. The holes 404 preferably have a beveled outer surface to receiveand guide the locking pins 402 into the holes 404. With the locking pins402 received in the holes 404 the head and anvil portion of the staplerwill be properly aligned. The pins 402 may be moved by the same firingmechanism as the staples and the blade as shown in FIG. 9. A separatepin movement mechanism may also be provided. It is important that thepins 402 be engaged with the holes 404 prior to the engagement of thestaples or the knife blade with the lumen tissue, since it is the pins402 which are assuring the alignment of the head and anvil portions.Consequently where a single firing mechanism is utilized the pins 402should be axially ahead of the staple and knife blade portions as shownin an exagerated fashion in FIG. 9. Another feature of the presentinvention is to offset the anvil segments and the head segments suchthat the pins 402 of each head segment will lock the head segment to twocorresponding overlapping anvil segments. This will effectivelyinterlock all of the head and anvil segments during firing to provide aconventional solid hoop structure for these components during the staplefiring and knife trimming operation. It should be apparent that thisalignment mechanism 400 will be applicable to EEA devices that do nothave separate head and anvil segments.

Various modifications to this invention are contemplated within thescope of the present invention. For example, additional clamping betweenthe stapling units 310 may be accomplished by having the alignmentmechanism on each stapling unit 310 (i.e., the rod 330 and lockingprojection 332) be independently axially movable such that when the twostapling units 310 are clamped together, axial movement of theassociated alignment mechanism will move the two stapling units 310closer together (or farther apart) to accommodate the desired clamping.Another modification of the present invention would be to connect thefiring of one stapling unit 310 to the firing of the other stapling unit310, such as through the associated alignment mechanism, so that theuser need only pull one trigger 334 to fire the two halves of staples14. Another modification to the present invention would be to form theseparate units as having an entire array of staples on one stapling unit310 and two anvil portions on the other stapling unit 310. However, thepresent invention simplifies the manufacturing of the stapler 300 byforming an entire stapler 300 of two identical stapling units 310.Regardless, these and other modifications make it clear that variouschanges to the present invention can be accomplished without departingfrom the spirit and scope thereof. For example, the staples 14 could bereplaced with another type of fastener. The described embodiments aremerely intended to be illustrative of the present invention and notrestrictive thereof. The scope of the present invention is intended tobe defined by the appended claims and equivalents thereof.

1.-75. (canceled)
 76. An external anastomotic stapler comprising twosubstantially identical, separate stapling units received around thelumen portions and coupled together with an alignment mechanism, whereineach stapling unit includes at least two sections, connectedlongitudinally by a hinge, said hinge extending longitudinally along thelength of the stapling unit.
 77. The anastomotic stapler of claim 76,wherein each stapling unit includes two semi-circular sections connectedlongitudinally by a hinge, said hinge extending longitudinally along thelength of the stapling unit.
 78. The anastomotic stapler of claim 77,wherein a first semi-circular section is formed as an anvil, and asecond semi-circular section comprises a stapling mechanism and a knifeportion.
 79. The anastomotic stapler of claim 78, wherein the firstsemi-circular section includes a series of staple receiving slots and aknife receiving groove, said knife receiving groove situated at theradially outer edge of the first semi-circular section, and wherein thesecond semi-circular section includes the knife portion situated at theradially outer edge thereof.
 80. The anastomotic stapler of claim 78,wherein the separate stapling units may be engaged face-to-face suchthat staples fired from the stapling mechanism of a first stapling unitmay be received in the anvil of a second stapling unit upon firing, andstaples fired from the stapling mechanism of a second stapling unit maybe received in the anvil of the first stapling unit upon firing in theopposite direction.
 81. The anastomotic stapler of claim 80, furthercomprising at least pin forming the alignment and allowing for alignmentof the separate stapling units when engaged face-to-face.
 82. Theanastomotic stapler of claim 76, wherein said stapler may be fired fromone end of the device.
 83. The anastomotic stapler of claim 76, whereineach stapling unit further comprises a plurality of tissue retractionmembers spaced around the periphery of each stapling unit. 84.-88.(canceled)
 89. An extraluminal intestinal stapler for end to endanastomosis formed of two opposed stapling units; each unit clampingaround a lumen section to be anastomized; wherein each said staplingunit comprises two halves hinged together, and wherein one half of eachunit is a stapling unit and the other half is an anvil portion.
 90. Thestapler of claim 89, further including a mechanism for pulling the lumento be attached across the stapling face of each stapling unit.
 91. Thestapler of claim 89, further including an alignment mechanism foraligning the two adjacent stapling units prior to firing a ring ofstaples. 92.-188. (canceled)
 189. An extraluminal stapler for end to endanastomosis formed of two opposed generally identical, opposed staplingunits; each unit clamping around a lumen section to be anastomized;wherein each said stapling unit comprises two halves, and wherein onehalf of each unit is a stapling unit and the other half is an anvilportion.
 190. The stapler of claim 189, further including a mechanismfor pulling the lumen to be attached across the stapling face of eachstapling unit.
 191. The stapler of claim 190, further including analignment mechanism for aligning the two adjacent stapling units priorto firing a ring of staples.
 192. The stapler of claim 190 wherein thetissue pulling mechanism includes a tissue grasping and positioningmechanism for positioning a lumen portion to be anastomized across thestapling face of the stapler in end to end anastomosis.
 193. The staplerof claim 190 wherein the tissue pulling mechanism includes a series ofidentical tissue grasping clips, each clip formed of a flexible strip ofmaterial, the clips being secured around the edge of a lumen portion tobe anastomized through snap fit connections with the clips providing forgrasping and for positioning the lumen portion across the stapling faceof a surgical sapling unit. 194.-200. (canceled)
 201. The stapler ofclaim 190 wherein the tissue pulling mechanism includes a tissuemanipulator for attachment to tissue to be manipulated by a surgeon, thetissue manipulator comprising: A) an elongated band attachable to thetissue; B) a tissue attachment mechanism on a first side of theelongated band for attaching the tissue manipulator to the tissue; andC) at least one manipulator on a second side of the elongated band,whereby the surgeon manipulates the tissue through the at least onemanipulator that transfers the manipulation forces to the tissuegenerally evenly along the elongated band to minimize tissue damage.202. The stapler of claim 201, wherein the elongated band is a flexiblemember adapted to be folded along an axis thereof about the tissue. 203.The stapler of claim 202, wherein the tissue attachment mechanismincludes a plurality of snap fit connections.
 204. The stapler of claim202, wherein the tissue attachment mechanism includes adhesive on thefirst side of the elongated band. 205.-207. (canceled)